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Quality Control Specialist Jobs

Company

Vertex Pharmaceuticals
Address , Boston, 02210, Ma
Employment type FULL_TIME
Salary
Expires 2023-10-04
Posted at 9 months ago
Job Description
General Summary:
The Quality Control Specialist supports with a variety of analytical functions that occur in the QC department supporting validation, testing and reporting of in-process, release and stability samples. This role also helps ensure activities occur in an efficient and cGMP compliant manner while fostering the Vertex vision and values.
Key Duties and Responsibilities:
  • Participate in compliance related teams working towards the goal of continuous improvement
  • Participate in author and review of data, SOPs, COAs, analytical methods, protocols and reports
  • Report OOT/OOS results and other deviations to area management and help remediate issues
  • Assist in troubleshooting of analytical methods and/or equipment as required
  • Maintain accurate laboratory records and adhere to cGMP/GDP expectations
  • Perform in-process, release, and stability testing and/or review independently following established methodology, procedures and SOPs
  • Perform other laboratory duties as assigned
  • Participate in executing and/or review of method validations, method transfers and/or equipment qualification/requalification
Knowledge and Skills:
  • Knowledge of analytical methodologies such as chromatography, dissolution, and Karl Fisher and applying/interpretation of GMP requirements
  • Effective communication skills, both verbal and written
  • Knowledge of US and EU cGMP regulations/guidance and some experience with regulatory agency inspections
  • The ability to work in a fast-paced environment, manage priorities and maintain timelines for multiple projects is essential
  • Strong attention to detail
Education and Experience:
  • Bachelor's Degree in science or related discipline is required.
  • Typically requires 4+ years of experience in GMP pharmaceutical/biopharmaceutical industry, or the equivalent combination of education and experience
Company Information
Vertex is a global biotechnology company that invests in scientific innovation.
Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.
Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at [email protected].